Welcome to our dedicated page for Y-Mabs Therapeutics news (Ticker: YMAB), a resource for investors and traders seeking the latest updates and insights on Y-Mabs Therapeutics stock.
Y-mAbs Therapeutics, Inc. (YMAB) is a commercial-stage biopharmaceutical leader pioneering antibody-based therapies and radioimmunotherapy for pediatric and adult cancers. This page provides investors and medical professionals with comprehensive access to Y-mAbs' official news, including FDA regulatory updates, clinical trial results, and strategic partnership announcements.
As the developer of DANYELZA – an FDA-approved treatment for high-risk neuroblastoma – Y-mAbs demonstrates ongoing innovation through its SADA PRIT platform and bispecific antibody research. Our curated news collection enables stakeholders to track the company's progress in advancing precision oncology treatments while maintaining compliance with rigorous clinical standards.
Key updates include press releases on product commercialization milestones, peer-reviewed study publications, and developments in the company's pipeline targeting GD2-expressing tumors. All content is sourced directly from Y-mAbs Therapeutics and verified financial disclosures to ensure reliability.
Bookmark this page for real-time updates on YMAB's scientific advancements and market-moving developments. Investors can leverage this resource to monitor the company's progress in bringing novel radioimmunotherapies through clinical trials to commercialization.
Y-mAbs Therapeutics, focused on innovative cancer treatments, announced the presentation of three-year follow-up data for DANYELZA and GM-CSF in high-risk neuroblastoma patients at the ASCO Virtual Annual Meeting on June 4, 2021. The study included 73 patients, showing a three-year event-free survival of 74% for first complete remission and 19% for later remissions. Overall survival rates were 92% and 66%, respectively. The positive data suggests DANYELZA's potential to differentiate itself from existing therapies if approved.
Y-mAbs Therapeutics (Nasdaq: YMAB) announced interim results from a phase 1 dose-escalation study for omburtamab targeting diffuse intrinsic pontine glioma (DIPG) at the ASCO Virtual Annual Meeting on June 4, 2021. The study demonstrated good tolerability with a median overall survival improvement of 3-4 months over historical controls. The company plans to advance this promising candidate into a phase 2 study later this year, further expanding the omburtamab franchise to include other CNS tumors. The study's positive data marks a significant step in addressing an unmet medical need in cancer treatment.
Y-mAbs Therapeutics announced an exclusive distribution agreement with Adium Pharma for Latin America, covering DANYELZA® and the investigational drug omburtamab. DANYELZA, approved by the FDA in 2020, targets high-risk neuroblastoma in pediatric patients. Omburtamab is pending approval for CNS metastasis treatment. The agreement grants Adium distribution rights in 18 countries, enhancing market access. Y-mAbs aims to submit further applications for omburtamab by late Q2 or early Q3 2021. Financial terms were not disclosed.
Y-mAbs Therapeutics announced a presentation by Dr. Nai-Kong V. Cheung at the PEGS Boston Virtual Conference on May 13, 2021, focusing on their SADA technology platform for cancer treatment. The SADA technology aims to enhance the therapeutic index in radioimmunotherapy, potentially improving treatment outcomes while minimizing toxicity. Y-mAbs is a biopharmaceutical company with a strong pipeline, including the FDA-approved DANYELZA® and the pivotal-stage candidate omburtamab. The technology is exclusively licensed from Memorial Sloan Kettering Cancer Center and MIT.
Y-mAbs Therapeutics, Inc. (Nasdaq: YMAB) reported strong financial results for Q1 2021, with net income of $33.4 million, or $0.80 per basic share, driven by DANYELZA® sales and Priority Review Voucher monetization. Revenue reached $5.4 million from DANYELZA, marking significant growth from zero in Q1 2020. Operating expenses increased, with R&D expenses at $21.6 million and SG&A expenses at $12.0 million. Cash and equivalents totaled $252 million, providing a solid position for advancing their pipeline, including the application for omburtamab in Europe.
Y-mAbs Therapeutics (Nasdaq: YMAB) will release its Q1 2021 financial results on May 6, 2021, followed by a conference call on May 7, 2021, at 9 a.m. ET. The call will include updates from key executives: Chairman Thomas Gad, CEO Dr. Claus Moller, and CFO Bo Kruse. Y-mAbs focuses on developing antibody-based cancer therapies, with one FDA approved product, DANYELZA®, and another candidate, omburtamab, in pivotal stages. Forward-looking statements are included, highlighting potential risks in clinical trials and market acceptance.
Y-mAbs Therapeutics, Inc. (Nasdaq: YMAB) has announced the acceptance of two poster presentations for DANYELZA and an oral presentation for omburtamab at the American Society of Clinical Oncology Virtual Annual Meeting from June 4-8, 2021. Key topics include the efficacy of naxitamab in high-risk neuroblastoma and a Phase 1 trial of omburtamab for diffuse intrinsic pontine glioma. The collaborations involve researchers from Memorial Sloan Kettering Cancer Center and SJD Barcelona Children's Hospital. Y-mAbs focuses on antibody-based cancer therapeutics, with a pipeline including DANYELZA, which is FDA-approved.
Y-mAbs Therapeutics has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency for omburtamab, a monoclonal antibody targeting B7-H3, aimed at treating pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma. This submission could position omburtamab as the first EMA-approved targeted therapy for this condition. Additionally, Y-mAbs plans to resubmit its Biologics License Application (BLA) to the FDA in late Q2 or early Q3 2021, highlighting its commitment to addressing a significant unmet medical need in pediatric oncology.
Y-mAbs Therapeutics, Inc. (Nasdaq: YMAB) announced a regulatory update for its investigational monoclonal antibody omburtamab, which targets B7-H3 for treating pediatric CNS metastasis from neuroblastoma. Following a Type B meeting with the FDA, additional data requests were made regarding historical control groups. Y-mAbs aims to resubmit its Biologics License Application (BLA) by mid-2021, with further discussions scheduled for June 1. The company is also targeting a Marketing Authorization Application submission to the European Medicines Agency by April 30, 2021.
Y-mAbs Therapeutics, a biopharmaceutical company, recently presented its SADA technology platform at the AACR Annual Meeting on April 10, 2021. This platform aims to improve radioimmunotherapy for colorectal peritoneal carcinomatosis. The GPA33-SADA construct demonstrated a favorable tumor-to-blood radioactivity ratio of 122. Y-mAbs plans to submit its first IND for this construct in 2022, having licensed the technology from MSK and MIT. The company is focused on developing antibody-based cancer treatments, including the FDA-approved DANYELZA.
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